A study to see if a new breathing device called the indigenous HFNC to give oxygen and humidification help people with acute breathing problems more effectively than the standard HFNC device

Efficacy of indigenous High Flow Nasal Cannula (HFNC) device in acute hypoxemic respiratory failure when compared to standard HFNC device - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056098

Enrollment

103

Registered

2023-08-03

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J960- Acute respiratory failure

Interventions

Intervention1: high-flow nasal cannula oxygen : Indegenous device which gives Humidified and heated oxygen with a gas flow through nasal cannula and inspired fraction of oxygen adjusted in order to m

Eligibility

Inclusion criteria

Inclusion criteria: 1. The eligibility criteria for this study would be (1) Inborn babies with respiratory distress (clinical / laboratory) 2. RSS Mild to moderate 3. SPO2 4. In preterm 88-92% ( 5. Signs of increased work of breathing on low oxygen

Exclusion criteria

Exclusion criteria: • RSS scoring: Severe respiratory distress • Underlying hemodynamic instability • Congenital heart disease which is critical • midfacial anomalies prohibiting the use of nasal cannula and • those requiring immediate intubation and ventilation because of apnea, respiratory failure, or profound hypoxemia • Do not Resuscitate (DNR)

Design outcomes

Primary

Measure	Time frame
Improvement in oxygentation via SPO2, PaO2Timepoint: Baseline, 2hr, 8 hr, 12 hr, 24 hr, 48, hr, 90 days	—

Secondary

Measure	Time frame
To determine the changes in the FiO2 requirement, improvement in PCO2 levels, hospital lengths of stay, 90-d mortality, & adverse effects after the HFNC treatment when compared to standard HFNC deviceTimepoint: 90-d mortality	—

Countries

India

Contacts

Public ContactSaumy Johnson

Amrita Institute of Medical Sciences, Kochi

saumyjohnson@gmail.com7909220456

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026